EN 14561:2006

Reference details

Reference

EN 14561:2006

Title

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)

Organisation

CEN

Publisher status in source

PublishedThis is the status recorded in the source, not a statement that this is the latest edition.

Source access

19 October 2026

Research and application

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Product research routes

• Medical devices

  Intended medical purpose, device classification and the evidence associated with design, performance and lifecycle controls.

• Measurement, test and laboratory equipment

  Measurement function, accuracy claims, electrical safety and the conditions under which results are comparable.

• Chemicals, plastics and rubber

  Substance identity, material properties, sampling and analytical methods across chemical and polymer products.

Questions for the evidence file

• Intended purpose
• Classification rationale
• Risk management
• Verification and performance evidence
• Clinical evidence scope
• Measurement model

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Legislation reference records

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Other indexed references in this family

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